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  1. Regulatory Procedures Manual

Chapter Summary

INTRODUCTION

Ch. 1 – REGULATORY ORGANIZATION – An overview of offices involved in compliance related functions within FDA.

Ch. 2 – FDA AUTHORITY – Selected Amendments to the Federal Food, Drug, and Cosmetic Act and other laws of interest.

Ch. 3 – COMMISSIONING AND WORK SHARING – Commissioning of Federal, State, and local officials, acceptance of a state’s commission, and work sharing initiatives.

Ch. 4 – ADVISORY ACTIONS – Procedures for Warning Letters and Untitled Letters.

Ch. 5 – ADMINISTRATIVE ACTIONS – Procedures for: Citation; Section 305 Meetings; Administrative Detention of Foods; Administrative Detention of Devices; License Revocation or Suspension; Orders for Retention, Recall, Destruction and Cessation of Manufacturing related to Human Cell, Tissue, and cellular and Tissue Based Products (HCT/Ps); Civil Money Penalties; and Disqualification of Clinical Investigators.

Ch. 6 – JUDICIAL ACTIONS – Procedures for: Seizures; Injunctions; Inspection Warrants; Search Warrants; Prosecution; and Civil Penalties under Subchapter C of the Federal Food, Drug, and Cosmetic Act.

Ch. 7 – RECALL PROCEDURES - Procedures for Agency units to initiate, review, classify, publish, audit, and terminate recall actions.

Ch. 8 – EMERGENCY PROCEDURES - Emergency management procedures for FDA’s headquarters and field personnel.

Ch. 9 – IMPORT OPERATIONS/ACTIONS – Includes: Import Procedures; Coverage of Personal Importations; Importation of Biological Products; Warehouse Entries; Release Notices; Automatic Detentions; Notice of Detention and Hearing; Responses to Notice of Detention and Hearing; Notice of Refusal of Admission; Reconditioning; Supervisory Charges; Bond Actions; Import Information Directives; Priority Enforcement Strategy for Problem Importers; Import for Export; Importations for Trade Shows/Fairs, Exhibits and Special Events; Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs Service in Cases Involving Imported Food; Notice of Sampling; and, Granting and Denying Transportation and Exportation (T&E) Entries.

Ch. 10 – OTHER PROCEDURES – Includes: Communications - District and Center Responsibilities; Prior Notice; Regulatory Meetings; Inspection of Food Records; Establishment Inspection Report (EIR) Conclusions and Decisions; Interstate Travel Program (ITP) Classifications and Administrative Actions; Reporting and Monitoring; Ad Hoc Committees; the Appeal Process; Expert Support for Cases; Testimony; Production and Certification of Records; and the Application Integrity Policy.

Ch. 11 – GLOSSARY – Terms and Acronyms used in the RPM.

APPENDIX A - RPM CHANGE REQUEST FORM.